17
Mar
2011

Cl ll IMPAX Remote Cardiology Review Station

0

Company: AGFA Corp.
Date of Enforcement Report 3/23/2011
Class ll:

PRODUCT
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8; Catalog Number CM 60+ 00091915. Recall # Z-1676-2011

REASON
A discrepancy in the validation testing which resulted in the product not performing as intended.

RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated February 10, 2011.
Manufacturer: AGFA healthcare Corp., Westerly, RI. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1 units

DISTRIBUTION
TX

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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